METHODS: Eighteen databases were searched, from inception to September 2010, irrespective of language. Inclusion criteria were that the study (1) was original peer-reviewed research, (2) included children from birth to 17 years, inclusively, (3) involved needle acupuncture, and (4) included assessment of AEs in a child. Safety data were extracted from all included studies.

CONCLUSIONS: Of the AEs associated with pediatric needle acupuncture, a majority of them were mild in severity. Many of the serious AEs might have been caused by substandard practice. Our results support those from adult studies, which have found that acupuncture is safe when performed by appropriately trained practitioners.

Acupuncture therapy is believed to have developed in China over thousands of years and refers to the stimulation of precisely defined, specific points on meridians (or channels) that lie along the surface of the body and within organs. Stimulation of acupoints can be accomplished through a variety of methods including application of heat, pressure, or laser or insertion of thin needles.1

Acupuncture is a popular treatment modality in many parts of the world. A 2007 US study estimated that 3 million adults use acupuncture, up from ∼2 million people in 2002. Among US children, it has been estimated that 150 000 (0.2%) used acupuncture in 2007.2 Canadian figures indicate that 12% of the population has ever used acupuncture and that 2% used acupuncture in 2003.3,4 Use among specific patient populations is frequently much higher (ie, up to 47.5%).5,–,8

Studies on the safety of acupuncture have been conducted; however, none of them have reported specifically on the safety of pediatric acupuncture. In a study published in 2009, the authors prospectively surveyed 229 230 patients (mean age: 46 years) for adverse acupuncture effects.9 A total of 19 726 patients (8.6%) experienced at least 1 adverse effect, and 2.2% of patients required treatment. The most common adverse effects were bleeding (6.1% of patients) and pain (1.7% of patients). In a 2005 study of >9400 consecutive adult patients, short-term reactions to acupuncture, both positive and negative, were documented.10 Of the 15 745 reactions reported, 68% were positive and included feeling relaxed and energized, whereas 18% were negative and included pain, discomfort or bleeding, bruising, vasovagal reactions, and worsening of condition; 14% of all reports were of tiredness or drowsiness. The rate of occurrence of these 2 latter categories of adverse events (AEs) was reported as 53.9 in 100 treatment sessions; tiredness/drowsiness and pain at insertion accounted for 24.4% and 12% of them, respectively. Only 13 (0.14%) patients were unwilling to have acupuncture again because of short-term reactions. The authors of a meta-analysis in which the safety of acupuncture was reviewed concluded that the risk of serious events associated with acupuncture was 5 per 1 million treatment sessions.11 The authors did not specify if this estimate included adults and children, but of the 12 studies in the meta-analysis, 2 included only adults and 4 included a small proportion of children, whereas for the remaining 6 studies, age-related information was not available from either the publications or the authors. In all cases, details about the patients in whom the AEs occurred, including age, were not reported. There is general consensus that acupuncture is safe if performed by appropriately trained practitioners, and no distinction has been made between adults and children in this conclusion.12,–,24

In a recent review of the literature, Jindal et al25 presented a summary of pediatric acupuncture safety. Despite the fact that randomized controlled trials (RCTs) are known to underestimate rare harms,26,27 their review was limited to RCT evidence of 4 different acupoint stimulation techniques: needle (with and without electrical stimulation) (5 studies); laser (3 studies); and acupoint injection (1 study). The authors identified a total of 29 predominantly mild AEs that occurred in either acupuncture treatment arms or control arms and presented a combined AE-incidence rate of 1.6 in 100 treatments.

To our knowledge, a systematic review of pediatric acupuncture safety has not yet been published. The purpose of this review was to systematically collect and synthesize all published reports of pediatric AEs associated with needle acupuncture.

Study Selection

Titles and abstracts of identified studies were screened independently by 2 reviewers. Full texts of potentially relevant studies were obtained and reviewed for inclusion on the basis of predetermined criteria. Disagreement was resolved by discussion.

Studies were included if they (1) contained original patient data published in a peer-reviewed journal, (2) included children from birth to 17 years, inclusively, (3) involved needle acupuncture, and (4) included assessment of AEs in a child. Note that we searched for reports that mentioned safety or harm/AEs as assessed and reported by the authors. Studies were not excluded for lack of harm/AEs but for lack of mention of safety/harm/AE assessment. Studies in which no harm/AEs had reportedly occurred were included in the systematic review.

Inclusion of studies in this review was not limited by any other variables.

Data Extraction

Data were extracted by 1 reviewer using standardized forms and verified by a second reviewer. Disagreement was resolved by discussion. The following information was extracted: author(s); year, country, and language of publication; study design; number, age, and gender of participants; reasons for seeking acupuncture; comorbid conditions and concomitant treatments; details of acupuncture and control treatments; practitioner qualifications; and details of AEs. If necessary, the principal authors were contacted for further details.

Data Synthesis

AE severity was assessed independently by 2 reviewers and was based on the Common Terminology Criteria for Adverse Events (CTCAE) scale.28 The categories were mild (minor, no specific medical intervention), moderate (minimal, local, or noninvasive intervention), or serious (required hospitalization or invasive procedures, resulted in persistent or significant disability/incapacity, was life-threatening, or resulted in death). Disagreement between reviewers was resolved by discussion, and if necessary, a third party was consulted.

The degree of association between the intervention and the AE was independently assessed by 2 reviewers using the causality algorithm used by Health Canada and the World Health Organization Collaborating Centre for International Drug Monitoring; terminology was modified for use in a device rather than for a therapeutic product.29 The categories for assessment were certain, probable/likely, possible, unlikely, conditional/unclassified, and inaccessible/unclassifiable. Disagreement between reviewers was resolved by discussion, and if necessary, a third party was consulted.

Results were presented as descriptive summaries. AEs in treatment and control groups (for 2-arm studies) were tallied separately to examine differences in incidence between these 2 groups. Because some acupuncture control groups used a different form of needle acupuncture as a control, all AEs that occurred in needle-acupuncture groups, treatment or control, were also tallied. Incidences are presented on the basis of the number of patients. Only those AEs that were adjudicated as possibly, probably/likely, or certainly caused by acupuncture, from prospective studies, were included in the calculations. Differences in AE occurrence between groups were examined by using χ2 tests.

RESULTS

Searches resulted in a total of 9537 references, of which 4249 were duplicates. After screening titles and abstracts of the remaining 5288 references, 4838 were excluded because of a lack of relevance to topic, lack of primary data, or lack of mention of safety or AEs; the full texts of the 450 potentially relevant articles were obtained. Of these articles, 29 representing 28 studies met all inclusion criteria (the results of 1 study were published as 2 different articles). Nine additional included studies were found through review of reference lists. Of the total of 38 included publications, 30 were published in English, 5 were published in Chinese, and 1 each was published in French, German, and Japanese.

Articles were excluded for the following reasons: full publication data were not available (5); there was duplicate publication of material (5); there were no primary patient data (48); the subjects were not human (3); no children were included (172); the study did not involve needle acupuncture (60); and information about AEs was not reported (128).

Of the 37 included studies, 9 were RCTs, 6 were cohort studies, and 22 were case reports or case series. Four studies included adults and children, whereas 33 included only pediatric participants. Of these 4 studies, pediatric data were presented separately or further information on patient ages and AEs was obtained from study authors. The flow of articles through the review is shown in Fig 1.

A total of 279 AEs were identified by the authors of the included studies: 146 from the RCTs, 95 from the cohort studies, and 38 from the case reports/series. Of these AEs, 253 were adjudicated in our review process as mild, 1 as moderate, and 25 as serious. Two serious AEs were rated as unlikely to have been caused by the acupuncture (details to follow). For the remaining AEs, causality was assessed as possible (167), probably/likely (53), or certain (57).

The 12 cases of thumb deformity, which occurred in 4 boys and 8 girls aged 3 to 11 years, were reported from a clinic in China between 1983 and 1989. Nine of the children had a history of acupuncture at the Hegu point, accompanied with use of Western medicines, whereas 3 patients had acupuncture alone; however, the reasons for and the details of the acupuncture treatments were not reported. The deformities usually presented ∼1 year after acupuncture treatment; the longest time before presentation was 5 years. Nine patients had fibrosis of the thumb adduction muscle, and the 3 remaining patients had fibrotic changes. All 12 patients underwent corrective surgery.30

In the first case of infection, a 17-year-old boy in France who was being treated for tendonitis was diagnosed with HIV infection. The first symptom (fever) developed during the week after the end of acupuncture treatment, and test results were suggestive of early HIV infection. Because other risk factors for HIV were excluded, the author of the primary article linked the infection to the preceding acupuncture treatment.31

In the second case, a 14-year-old girl in Taiwan who was being treated for mild gluteal pain developed septic sacroiliitis within 1 day of acupuncture treatment. Her condition resolved within 10 days, after hospitalization and treatment with intravenous antibiotics and analgesics.32

In the third case, a 13-year-old boy in Japan who was being treated for lumbar pain developed fever and pain 1 day after acupuncture treatment and was diagnosed with septic arthritis of a lumbar facet joint. After hospitalization and treatment with antibiotics, his symptoms resolved within 1 week.33

In the fourth case, a 15-year-old boy in the United States was treated for thoracic spinal pain with chiropracty and acupuncture. After the development of fever several weeks later, radiographs identified a paravertebral soft tissue mass diagnosed as pyogenic spondylitis. Biopsy results indicated bacterial infection that was resolved through an extended course of antibiotics.34

In the fifth case, a 12-year-old girl in Taiwan was admitted to the hospital with a Pott's puffy tumor (subperiosteal abscess and osteomyelitis of the frontal bone). She had previously received acupuncture for her neurologic condition. Emergency surgery was performed to drain the abscess, and culture confirmed bacterial infection at the site. The patient was discharged in stable condition.35

In the case of cardiac rupture, a 9-year-old boy in China received acupuncture to the chest and abdomen. He was being treated for preexisting conditions including malnutrition, pulmonary tuberculosis, and heart disease, for which other care had failed. During the sixth treatment the boy experienced severe chest pain and died shortly after. The autopsy revealed that the patient had a severely enlarged heart. Needle holes were found in the diaphragm, pericardium, and right ventricular wall, which led the examiner to conclude that death occurred as a result of puncture of the heart and subsequent rupture.36

The case of pneumothorax involved a 15-year-old girl in France who became symptomatic during acupuncture treatment for an acute asthma attack and was immediately hospitalized. The patient recovered, and 3 months later, signs of lung scarring were observed at the needling location.37

In the case of nerve impairment, a 16-year-old boy in Japan with a history of fatigue, tachycardia, and constipation was treated in such a way that >70 needles were found embedded throughout his body during later investigations; 1 needle was located in the spinal canal between the first and second cervical vertebrae. Symptoms of nerve impairment began soon after acupuncture treatment and progressed over 2 years to numbness in both legs and 1 arm. Surgery to remove the cervical needle resulted in good recovery from muscle weakness but sensation remained impaired.38

The case of subarachnoid hemorrhage involved an 11-year old girl in China who experienced headache and vomiting after acupuncture for limited hearing and speech abilities. She was hospitalized for 1 week with a diagnosis of traumatic subarachnoid hemorrhage. Acupuncture treatment included insertion of a needle to ∼2 inches slightly above the thyroid cartilage. The authors concluded that the treatment possibly led to damage of the meningeal or cephalic blood vessels. No other causative factors could be identified for her symptoms. Examination 2 months later was normal.39

In the case of intestinal obstruction, a 2-year-old boy with diarrhea was treated with acupuncture at a clinic in China. After treatment the boy exhibited periodic crying, refusal to eat, vomiting, constipation, stopped production of gas and bowel movement, and general worsening of symptoms. The patient was admitted to hospital with abdominal tenderness. Conservative treatment was unsuccessful; exploratory surgery revealed an egg-sized hematoma that was obstructing the intestine. The affected section of intestine was removed, and the patient recovered.40

The case of hemoptysis involved a 15-year-old boy in China who was bedridden and in a vegetative state as a result of complications of epilepsy. He was treated with acupuncture in the chin region for his encephalopathy; soon after that, his condition worsened and he was diagnosed with persistent hemoptysis. After radiograph identification of a wire in his lower right thorax, surgery was conducted and a 7-cm acupuncture needle was removed. The patient was treated with antibiotics and recovered. It is believed that a needle was aspirated into his tracheostomy during acupuncture treatment.41

In the case of reversible coma, a 15-year-old boy in Canada received acupuncture treatment for musculoskeletal pain. During treatment, after laying on his right side for 30 minutes, the patient could not be roused and was taken to the emergency department. He was determined to be in a coma, from which he spontaneously awoke after ∼1 hour. After a similar incident at home 12 days later, further testing suggested that he had posterior cerebral hypoperfusion. Surgery was conducted to improve the perfusion, and the patient recovered and remained symptom-free during follow-up. The reversible coma was judged unlikely to be related to the acupuncture but, rather, related to his posture during treatment.42

The case of overnight hospitalization occurred during an RCT of acupuncture versus ondansetron versus saline for emesis related to dental anesthesia in Israel. The child (age and gender were not reported) was admitted for excessive vomiting after dental treatment under general anesthesia. The AE was rated as unlikely to be associated with acupuncture, because 3 other study participants were hospitalized for the same reason: 1 had received ondansetron control and 2 had received intravenous saline.43

Moderate AEs

The single moderate AE was a case of infection in a 16-year-old girl who developed severe bacterial infections at the site of ear stapling in both ears. She was being treated for weight loss with surgical staples, which were left in place, at an acupuncture parlor. Infection was noted 2 weeks later after complaint of ear pain and was treated with drainage and multiple courses of antibiotics44 (Table 1).

Mild AEs

The mild AEs included crying, pain, bruising, transient hemorrhage at the puncture site, numbness at the puncture site, aggravation of preexisting symptoms/condition, and vasovagal reactions such as dizziness or nausea/vomiting (Table 2). Most (158) mild AEs occurred under treatment by acupuncturists, 83 by physicians certified in acupuncture, 1 by a physician whose acupuncture credentials were not reported, and 11 by unspecified practitioners.

A total of 145 mild AEs occurred within RCTs, 7 in comparison to standard care and the rest in comparison to sham acupuncture, which consisted of pressure, minimal penetration at active points, or insertion at sham points.

AE Incidence

A summary of AEs, based on study design, is listed in Table 3. Three of the 8 RCTs collected AE data from both the acupuncture treatment and acupuncture control arms,45,46,52 whereas the other 5 collected AE data from the acupuncture treatment arms (compared with either acupressure or conventional care in the control arms).47,–,51 Four cohort studies also contributed usable acupuncture AE data.55,–,58 The 2 other cohort study reports did not provide reliable numerator and denominator values and were not included in the AE totals.53,67

Combining the AE data from both arms of all RCTs and the 4 cohort studies resulted in a total of 170 AEs of 1487 patients (11.4% [95% confidence interval (CI): 9.8–13.1]), and restricting data to only treatment and control arms that provided needle acupuncture resulted in a total of 168 AEs of 1422 patients (11.8% [95% CI: 10.1–13.5]).

Excluded Studies

A number of the excluded studies are worthy of further mention to promote transparency in our decision-making. We excluded 1 report of the insertion of multiple metal objects by a practitioner described as an African “specialist witchdoctor”; these objects were detected when the patient was hospitalized for acute rheumatic fever.68 Because we were uncertain if this treatment qualified as acupuncture, we chose to exclude it.

We also identified 11 other studies that included both children and adults, where, despite repeated requests to the authors, it remained unclear if any of the reported AEs occurred in children. Therefore, those studies were not included.14,69,–,77

DISCUSSION

To our knowledge, this is the first systematic review to specifically examine the safety of needle acupuncture in children. The majority of identified harms were mild and were from prospectively planned studies; few serious harms were identified. A large proportion of AEs identified from the RCTs were from 2 studies. In the first study, all 25 participants who received tongue acupuncture experienced initial crying with fear and possible minor pain.51 In the second study, all 30 participants who received traditional Chinese medicine acupuncture experienced local hemorrhage, crying, or irritability.52

The report by Jindal et al25 presented an overall AE incidence of 29 of 651 patients (4.5% [95% CI: 2.9–6.0]) for patients who received either real or sham acupoint stimulation. The results from breaking down the incidence according to type of acupuncture are listed in Table 4.

Acupuncture AE Rates Reported by Jindal et al25 for Study Arms in Which Participants Received Acupoint Stimulation (Real or Sham)

All of the AEs occurred in conjunction with needle acupuncture. The lack of AEs with laser acupuncture and acupoint injection might be because, in part, of inherent differences between the 3 procedures. If we consider the RCTs of needle acupuncture alone, to compare the results of Jindal et al with those of our systematic review, their determination of AEs from patients who received acupuncture treatment (8.3%) was significantly lower than ours (29.5% of patients) (P < .001). The methods used by Jindal et al differed from ours in 3 key ways: (1) the authors restricted their included studies to RCTs; (2) they searched for efficacy studies and subsequently screened for mention of safety; and (3) they included studies that did not report harms (both those that made no mention of harms and those that stated that no harm occurred; in our systematic review we differentiated between the two, because we did not see them as equivalent).

Problems in the Field

To be able to compare harms with other medical interventions, we chose to use a modified version of the National Cancer Institute Common Terminology Criteria for Adverse Events scale. A number of methods for classifying or categorizing harm exist; however, a standardized, broadly accepted method for categorizing the harms that might be associated with acupuncture is not yet in place despite earlier identification of such a need.78

Research Implications

The overall incidence of AEs in these 2 sets of pediatric-specific results are much lower (8.3% and 11.4%) than that reported for similar events in adults (up to 29.5%).10 This might be because, in part, of the much larger number of adult patients studied, as well as study design, in that the adult data were collected during a large-scale prospective practice survey. In an editorial published a decade ago, MacPherson78 strongly encouraged the conduct of prospective practice surveys as a way of gathering the strongest safety evidence and overcoming limitations of both retrospective surveys and literature reviews. Large-scale prospective practice-based surveys have since been carried out in multiple countries on several different styles of acupuncture, which led to convincing and reassuring safety information in adults. Repetition of this work in children would go far in closing this gap in pediatric safety knowledge and likely result in a more convincing estimate of risk of pediatric AEs.

Clinical Implications

Five of the serious AEs we identified might have involved technical error rather than inherent risk from the procedure. The cases of infection might have occurred as a result of inadequate sterilization, either of the site or needles, and the cases of cardiac rupture and pneumothorax as a result of improper technique or poor knowledge of anatomy. The case of cardiac rupture is particularly disturbing because of the numerous errors that were made, by modern standards, including the insertion of needles through clothing. Current acupuncture regulations79 precisely detail protocols intended to maximize the safety of acupuncture practice, including procedures for sterilization and needling in the area of organs, but it is unknown what regulations were in place at the times and places of these AEs. The case of nerve impairment might have been a result of a practice that was common in Japanese acupuncture and included deliberately breaking needles and permanently embedding them in the body.

Informed consent to any health care intervention demands accurate knowledge of potential risk and potential benefit. In conventional medicine, harms are not uncommon80,–,82 but are often accepted in light of the seriousness of the illness and the potential effectiveness of the therapy. In pediatric acupuncture, evidence of effectiveness is still being developed for most conditions. The acceptability of offering acupuncture as a treatment option then depends on its safety, cost, and tolerability. In our study we found the likelihood of serious harm to be very low in trained hands, and the more common mild AEs (nature and rate) are in line with what is known about subcutaneous needle penetration.83

Limitations

This study was limited by the restriction of searches to conventional English-language databases because of logistic considerations. Searches of non-English databases might have yielded further information. In some countries, international access to local literature might be difficult, because articles might not be indexed in conventional databases and because access to local journals might be restricted. For example, in their review of the Japanese acupuncture safety literature, Yamashita et al determined that of the 89 articles they found, 70 were not listed in PubMed.84 In some cases, as in Japan, authors are collecting and publishing this local information in more readily available forms.54 Others are collecting and synthesizing data from large numbers of their own studies.50

CONCLUSIONS

We identified common minor AEs and rare serious harms in pediatric acupuncture. Evaluation of the current pediatric literature identified few serious AEs; however, the small number of participants in the included studies hampers our ability to draw conclusions regarding the overall safety of pediatric acupuncture and to generalize to other populations. On the basis of the available data, we determined the incidence of mild AEs that occurred in needle-acupuncture study arms to be 168 of 1422 patients (11.8% [95% CI: 10.1–13.5]). Estimates of overall risk of AEs in adult acupuncture, including serious AEs, have been possible because of the conduct of large prospective studies. The current pediatric acupuncture safety literature is limited to case reports and small studies or the inclusion of small numbers of children in predominantly adult studies. To produce convincing risk estimates for pediatric acupuncture, prospective large-scale pediatric studies and standardized reporting criteria are needed. With the popularity of pediatric acupuncture, especially in patient populations, reliable information about its safety is urgently needed.

ACKNOWLEDGMENTS

This work was supported by Alberta Innovates-Health Solutions (formerly AHFMR) and the Canadian Institutes of Health Research. Dr Vohra receives salary support from Alberta Innovates-Health Solutions as a health scholar.

We thank Courtney Spelliscy, Sheena Sikora, and Kerri Gladwin for assistance with screening of the articles and Derek Wang for Chinese article screening and translation.

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